The yet to be approved `encapsulated’ Benzoyl Peroxide 5% Cream known as Epsolay has received a huge promotional boost after the rosacea heavyweight Galderma announced a 5 year exclusive license for the US market.
Having the backing of a significant licensing deal from Galderma behind them is good news for the owners of Epsolay. The experience from developing and marketing Metrogel, Oracea, Soolantra and Mirvaso will ensure Epsolay has the best possible chance of becoming a successful product.
Rosacea News has been following SOL-GEL’s product since 2009, having been variously known as DER45, VERED, S5G4T-1 and now Epsolay. Epsolay was due for approval in 2021, which is still unknown as COVID restrictions have delayed many aspects of the FDA’s drug approval processes.
Epsolay’s response by rosacea sufferers at large has yet to be determined.
Epsolay Galderma Press Release
NESS ZIONA, Israel & LAUSANNE, Switzerland, Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, and Galderma, the world’s largest independent dermatology company, today announced they have signed two exclusive 5-year license agreements for the commercialization of EPSOLAY and TWYNEO in the United States.
Under these agreements, Galderma has an exclusive license to commercialize Sol-Gel’s most advanced investigational drug products using Sol-Gel’s proprietary micro-encapsulation technology, in each case provided the product is approved by the FDA:
EPSOLAY (benzoyl peroxide, 5%, cream) is under investigation for the treatment of inflammatory lesions of rosacea in adults, with a Prescription Drug User Fee Act (PDUFA) goal date originally set for April 26, 2021. Action on the NDA for EPSOLAY has not yet been taken due to the inability of the FDA to conduct a pre-approval inspection of the production site of EPSOLAY due to COVID-19 travel restrictions.
TWYNEO (benzoyl peroxide, 3%, and tretinoin, 0.1%, cream) is under investigation for the treatment of acne vulgaris with a PDUFA goal date set for August 1, 2021.
Sol-Gel is entitled to up to $15 million in upfront payments and regulatory approval milestone payments assuming 2021 approval of both products. Sol-Gel is also eligible to receive tiered double-digit royalties ranging from mid-teen to high-teen percentage of net sales as well as up to $9 million in sales milestone payments.
“Galderma already owns the current market leading brands for rosacea and acne, and I am therefore delighted that Galderma views EPSOLAY and TWYNEO as innovative and with the potential to become key market brands,” stated Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Our partnerships with Galderma represent an important development for rosacea and acne patients while also strengthening our balance sheet by providing non-dilutive capital without compromising our desire to establish Sol-Gel as a leading dermatology company. We intend to remain focused on developing our promising pipeline and we are appreciative of the flexibility that these agreements provide through Sol-Gel retaining commercial rights after the initial five-year term,” commented Dr. Seri-Levy.
“Innovation is at the heart of our commitment to advancing dermatology,” said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. “The potential to deliver two innovative products featuring Sol-Gel’s proprietary micro-encapsulation technology represents an important milestone for acne and rosacea patients and underscores Galderma’s position as the partner of choice in dermatology.”
What is Epsolay?
We are told that Epsolay “utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to release benzoyl peroxide slowly over time to provide a favorable efficacy and safety profile.”
Benzoyl peroxide has typically been used to treat acne, and seen by many as too harsh for sensitive rosacea skin. It will be interesting for rosacea sufferers to obvserve Epsolay in the real world to see if it becomes a new viable option to treat the papules and pustules typically associated with rosacea.
For more information on the safety and potential side effects of Epsolay, see Epsolay is on its way, will it stay?
